Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Von Willebrand Diseases, Major Constitutional Thrombopathy, Patient on Antiplatelet Drugs. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions. An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy). The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions. Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
Interventions
- Biological Blood sampling
4 citrated/PPACK tubes and 1 EDTA tube maximum
Primary outcome measures
- Repeatability and reproducibility of the result in controls [Time frame: Baseline]
- Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- person who has given oral consent
- adult
- blood donor at EFS Bourgogne Franche-Comté
- or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
- or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital
Exclusion criteria
- a person who is not affiliated to or not a beneficiary of national health insurance
- person subject to court-ordered protection (curatorship, guardianship)
- pregnant, parturient or breastfeeding woman
- a person who is unable to consent
- person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- CHU de Besançon — Besançon
- CHU Dijon Bourgogne — Dijon
Identifiers
NCT: NCT03773159 · De MAISTRE ANR 2017